A ready-to-use integrated in vitro skin corrosion and irritation testing strategy using EpiSkin™ model in China

Abstract

The need of in vitro alternative methods has been increasing in toxicology research as well as in cosmetic industry in China recently. Following the establishment of China EpiSkin™ skin corrosion and irritation testing methods, both as stand-alone in vitro tests according to Organization for Economic Co-operation and Development (OECD) TG 431 and TG 439, the present study aims to evaluate the use of these two methods within the Integrated Approach on Testing and Assessment (IATA). The IATA, adopted by OECD as Guidance Document 203, provides guidance on the integration of existing and new data in a modular approach for classification and labelling of chemicals according to Globally Harmonized System of classification and labeling of chemicals (GHS) issued by the United Nations (UN). By applying bottom-up and top-down integrated testing strategies to a set of 60 chemicals representing various chemicals classes (organic acid/base/neutral, inorganic acid/base/salt, and surfactant) and physical states (liquid and solid), the results demonstrated that both strategies reached a high overall accuracy of 83.3% to distinguish non-classified, Category 2, Category 1B/1C and Category 1A according to UN GHS, identically. In conclusion, the integration of China EpiSkin™ skin corrosion and irritation testing data into either bottom-up or top-down strategy allows accurate assessment of potential skin hazard of chemicals. It brings a future extension of application of alternative methods and implementation of alternative testing strategies in China.